Advanced coronary artery disease: Appropriate end points for trials of novel therapies.
BACKGROUND: The segment of patients with advanced coronary artery disease, or disease that is not amenable to conventional revascularization therapies, continues to grow. Because the natural history of these patients is less defined, the appropriate end points for trials of novel revascularization therapies involving patients with advanced coronary artery disease are not certain. METHODS AND RESULTS: The Mediators of Social Support Study (MOSS) prospectively followed up outcomes of long-term survival, quality of life, resource use, and costs for 1189 patients and compared outcomes of patients with advanced coronary artery disease with those of a reference group who underwent bypass surgery or angioplasty. CONCLUSIONS: Despite greater disease burden, cost, and mortality for patients with advanced coronary artery disease, a number of self-reported measures of general health status improved in a similar fashion to that of patients eligible for angioplasty or bypass surgery. These findings should inform the design of trials involving novel therapies, suggesting that angina status and mortality be included as primary end points in the consideration of efficacy. This work also suggests that additional studies of novel therapies involving larger sample sizes may be required to confidently characterize efficacy.
Kandzari, DE; Lam, LC; Eisenstein, EL; Clapp-Channing, N; Fine, JT; Califf, RM; Mark, DB; Jollis, JG
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